Senior CRA – Level I

🕒 5 days ago

🇵🇪 Peru – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Contribute to selection of potential investigators • Support study start-up and regulatory maintenance, including site qualification, document preparation, tracking, and submissions to EC/IRB and regulatory authorities • Train, support, and advise Investigators and site staff on study-related matters and RbQM principles • Confirm required site-staff training, including ICH-GCP, and maintain inspection readiness • Participate in Local Study Team and National Investigators meetings • Initiate, monitor, and close study sites in compliance with applicable procedures • Share patient recruitment and site progress information within the LST • Drive site performance and resolve or escalate study-related issues • Update CTMS and other systems with study-site data • Manage study, drug, and drug-accountability supplies, including drug destruction when applicable • Perform remote and onsite monitoring visits and remote data checks according to the Monitoring Plan • Perform Source Data Review, Case Report Form review, and Source Data Verification • Conduct Site Quality Risk Assessments and adapt monitoring intensity • Ensure timely data-query resolution and collaborate with data management on study-data quality • Ensure accurate and timely Serious Adverse Event reporting and follow-up • Prepare and finalize monitoring visit reports in CTMS and provide feedback to Principal Investigators • Follow up on outstanding site actions • Escalate systematic or serious quality, privacy, CSP, or ICH-GCP compliance issues • Assist sites in maintaining inspection-ready Investigator Site Files • Support audits and regulatory inspections with LSAD and CQAD • Collect and upload essential documents to the eTMF and support quality-control checks • Ensure study documents are ready for final archiving and local eTMF completion • Provide research-related intelligence on sites, investigators, and competing studies for the local market • Ensure compliance with AstraZeneca’s Code of Ethics, company policies, procedures, and applicable legislation • Collaborate with local MSLs as directed

🎯 Requirements

• Minimum 3–5 years’ experience as a monitor • Ability to work independently and monitor all stages of a study across different phases • Special therapeutic expertise in oncology • Ability to take on LST tasks and support LST coordination or document preparation as required • Ability to travel internationally as required • Valid driving license • Knowledge and compliance with ICH-GCP, AZ Procedural Documents, local regulations, and relevant legislation • Ability to perform monitoring visits, remote data checks, SDR, CRF review, and SDV • Ability to manage study supplies, drug supplies, and drug accountability • Ability to use CTMS and other study systems • Ability to ensure timely SAE reporting, data query resolution, and essential document submission • Ability to collaborate with Investigators, site staff, Local Study Teams, data management, MSLs, LSAD, CQAD, and local management

🏖️ Benefits

• Fully remote work arrangement

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